Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia

Hospital General Universitario Gregorio Marañon

Status: Completed

Conditions: Monomorphic Ventricular Tachycardia

Treatments: Drug: Antiarrhythmic drug; Procedure: Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03734562

FIBHGM-0902

Details and patient eligibility

About

To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.

Full description

Sustained monomorphic ventricular tachycardia remains an important source of morbidity and mortality in patients surviving a myocardial infarction. ICD´s have been proven to reduce mortality in this patients population, nonetheless, recurrent arrhythmia and ICD shocks are known to negatively impact ventricular function and are associated with worsening heart failure and mortality. We devised a controlled, randomized, parallel, single blind, phase IV clinical trial with the aim of comparing the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia, implanted with an ICD.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic cardiomyopathy, with ischemic myocardial scar
• Sustained monomorphic ventricular tachycardia
• Age > 18 years
• Prior ICD implantation

Exclusion criteria

• VT storm
• NYHA functional class IV
• Additional indication for antiarrhythmic drug therapy
• Contraindication for both study drugs (amiodarone and sotalol).
• Uncontrolled myocardial ischemia.
• LV thrombus.
• Non-ischemic VT substrate.
• Contraindications for anticoagulation.
• Prior substrate ablation in the previous 6 months
• Cr > 2.5 mg/dL
• Mitral AND aortic mechanical valvular prosthesis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Ablation

Experimental group

Description:

Substrate-based radiofrequency catheter ablation

Treatment:

Procedure: Ablation

Antiarrhythmic drug therapy

Active Comparator group

Description:

Antiarrhythmic drug therapy; amiodarone or sotalol

Treatment:

Drug: Antiarrhythmic drug